eNews Nov 23, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

Respiratory assist system gets FDA clearance

Pittsburgh-based ALung Technologies, Inc., announced that the Food and Drug Administration granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung is indicated for respiratory support that provides extracorporeal carbon dioxide removal from the patient’s blood for up to five days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected. The FDA De Novo review process is designed to determine that the clinical benefits of a medical device outweigh the clinical risks associated with it in the absence of a substantially equivalent predicate device.

VC dollars needed for Medicaid patients

Venture capital dollars are pouring into digital health companies, but VCs shouldn’t forget companies whose technologies are tied to Medicaid patients, argues one VC, Justin Norden, in MedCity News. “Admittedly, Medicaid is not the market most entrepreneurs think about when starting a company for the first time, which is why it is even more critical for VCs to support these initiatives,” he writes. “Helping advance innovation in underserved populations is not a charity project, it is a need and opportunity from a dollars and cents perspective. We have the tech to make things better—and we should make them better for everyone.

Ischemic stroke intervention catches on

Quick intervention for an intracranial large-vessel occlusion (LVO), a common type of ischemic stroke, can improve patient outcomes, according to Vizient. With artificial intelligence (AI), an interventionalist could conceivably receive the LVO image on their mobile phone, evaluate the scan and book the procedure immediately. On Oct. 1, 2020, the Centers for Medicare & Medicaid Services implemented a reimbursement policy for AI-based LVO detection. By the first quarter of 2021, the number of Vizient members using the AI technology doubled.

Atherectomy for in-stent restenosis

Redwood City, California-based Avinger received 510(k) clearance from the FDA for a new clinical indication for the Pantheris image-guided atherectomy system. This clearance allows the company to directly market the technology for the treatment of in-stent restenosis (ISR) in the lower extremity arteries. Pantheris is designed to enable physicians to visualize stent struts and safely target ISR lesions to restore blood flow to occluded vessels, while avoiding the structure of the previously implanted stent. Approximately 200,000 stents are placed in the femoral and popliteal arteries annually, and 30% to 40% of them are expected to develop in-stent restenosis within three years of implantation, according to the company.